Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy

Plain-language summary

This study provides long-term follow-up of people who previously received a gene therapy called AAVAnc80-hOTOF for hearing loss caused by the otoferlin (OTOF) gene. Only participants who received this therapy into the cochlea in the AK-OTOF-101 clinical trial are eligible. Run by Akouos, Inc., this study does not use clinical phases and is enrolling by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Enrolling by invitation

Sponsor

Akouos, Inc.

Start date

11/11/2024

Estimated completion

4/1/2033

Countries

United States, Spain, Taiwan

Related genes

Locations

• Iowa City, United States
• Boston, United States
• Philadelphia, United States
• Esplugues de Llobregat, Spain
• Taipei, Taiwan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial
* Legally authorized representative and/or participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate)

Exclusion Criteria:

* Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study